MSCs For Treatment of Azoospermic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02025270
Recruitment Status : Recruiting
First Posted : January 1, 2014
Last Update Posted : June 29, 2016
Cairo University
Information provided by (Responsible Party):
Sayed Bakry, Al-Azhar University

Brief Summary:
In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.

Condition or disease Intervention/treatment Phase
Male Infertility Biological: Stem Cells Phase 1 Phase 2

Detailed Description:
Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients
Study Start Date : October 2012
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Arm Intervention/treatment
Laboratory and Clinical
60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into rete testis.
Biological: Stem Cells
60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.
Other Names:
  • Stem Cell Dose
  • 3-5 Million Autologous MSCs Injected into rete testis.

Primary Outcome Measures :
  1. All Cases Improvement [ Time Frame: One Year (12-Month) ]
    Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.

Secondary Outcome Measures :
  1. All Cases Fertility Improvement [ Time Frame: One Year (12-Month) ]
    Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency.

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All Non obstructive Azoospermic Patients.
  • Azoospermic Patients due to Administration of Chemo/Radiotherapy.

Exclusion Criteria:

  • Patients with Testicular Cancer.
  • Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02025270

Contact: Taimour M Khalifa, MD +201222115517
Contact: Sayed Bakry, PhD +201006609978

Al Azhar University , School of Medicine Recruiting
Nasr City, Cairo, Egypt, 11884
Contact: Sayed Bakry, PhD    +201006609978   
Principal Investigator: Taimour Khalifa, MD         
Sub-Investigator: Sayed Bakry, PhD         
Sub-Investigator: Hala Gabr, MD         
Sub-Investigator: Wael Abu El Khier, MD         
Sponsors and Collaborators
Al-Azhar University
Cairo University
Principal Investigator: Taimour M Khalifa, MD Professor Al-Azhar University
Study Director: Sayed Bakry, PhD Al-Azhar University
Study Chair: Hala Gabr, MD Cairo University
Study Chair: Wael Abu Elkhier, MD Miltary Academy
Study Chair: Saad Moneer, MSc Al-Azhar University
Study Chair: Yasser Aly Elsheikh, MD Chairman of Urology & Andrology Department- Al Galaa Military Complex
Study Chair: Ahmed Kadeh, MSc Al-Azhar University

Responsible Party: Sayed Bakry, Associate Professor , Consultant of Separation and Culturing of Stem Cells, Al-Azhar University Identifier: NCT02025270     History of Changes
Other Study ID Numbers: AZH010066099
Azhar23052011 ( Other Grant/Funding Number: Al Azhar University )
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Sayed Bakry, Al-Azhar University:
Azoospermia, Spermatogonial Arrest, Maturation Arrest.

Additional relevant MeSH terms:
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female